BPC April 11 update

Neurocrine (NBIX) receives FDA Approval for INGREZZA - shares up 19% AH; Contrasting fortunes for Axovant (AXON) and Cytori (CYTX) following pricing of offerings

Price and Volume Movers

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced after-hours Tuesday that the FDA has approved INGREZZA (valbenazine) for the treatment of adults with tardive dyskinesia (TD). INGREZZA is the first and only FDA-approved product indicated for the treatment of adults with TD. Shares are currently up 19% to $49.24 in the after-hour's session following news of no black box in the label, giving it a possible competitive edge.

Axovant Sciences Ltd. (NYSE: AXON) announced the pricing of its underwritten public offering of 6,742,179 shares at a price of $18.54 per share for gross proceeds of approximately $125m. Shares closed up 9% to $20.25.

Cytori Therapeutics, Inc. (NASDAQ:CYTX) also announced that it has priced its underwritten public offering of 8.6m shares at a price of $1.10 per share for gross proceeds of $9.5m. Shares tumbled to close down 35% to $1.12, a new reverse-split adjusted record low.

Windtree Therapeutics, Inc. (Nasdaq: WINT) shares closed up 21% to $1.50. The company announced that Data Safety Monitoring Board (DSMB) has completed its second and final interim safety review of the AEROSURF Phase 2b trial. The trial will continue through to completion with top-line data due mid-2017.

Agile Therapeutics, Inc. (Nasdaq:AGRX) reconfirmed its intention to resubmit its New Drug Application (NDA) for its contraceptive patch, Twirla. The resubmission is due by the end of 2Q 2017. The company noted that in a meeting with the FDA the agency indicated that based on the preliminary information provided by the company, the SECURE trial results appear acceptable for resubmission. Agile reported top-line results from its Phase 3 SECURE clinical trial in January 2017, which investors called below-par, resulting in shares losing almost half their value. Shares closed Tuesday’s session up 5% to $3.11.

Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) shares spiked up in early trading to open up 34% in response to its press release Tuesday morning that it had received minutes from a FDA meeting where the agency supported a single-study New Drug Application (NDA) of TNX-102 SL for the treatment of posttraumatic stress disorder (PTSD). Similar to recent press releases by small cap companies, the content of the release was relatively insignificant and this was evident in shares selling off later in the day to close up just 7% to $4.61.


Other major price movers:

ADVANCERS:

Neothetics Inc (NASDAQ:NEOT): $2.09; +15%.

Conatus Pharmaceuticals Inc (NASDAQ:CNAT): $6.98; +14%.

MannKind Corporation (NASDAQ:MNKD): $1.38; +10%.

ArQule, Inc. (NASDAQ:ARQL): $1.10; +9%.

Cerecor Inc (NASDAQ:CERC): $0.54; +8%.

 

DECLINERS: 

Akari Therapeutics PLC (ADR) (NASDAQ:AKTX): $17.16; -13%.

Oncomed Pharmaceuticals Inc (NASDAQ:OMED): $4.95; -11%.

Geron Corporation (NASDAQ:GERN): $2.33; -9%.

Rexahn Pharmaceuticals, Inc. (NYSEMKT:RNN): $0.618; -8%.

Aralez Pharmaceuticals Inc (NASDAQ:ARLZ): $1.71; -8%.

 

Full pipeline updates:

Pipeline Database Updates

Drug Stage Catalyst

AGRX
Twirla
Contraceptive patch

Phase 3 CRL issued 2013. Phase 3 top-line data released January 3, 2017 - poor data but reconfirmed April 11, 2017 its intention to reflile NDA 2Q 2017.

CBIO
CB 2679d/ ISU304
Hemophilia B

Phase 1/2 Phase 1/2 trial planned for 2Q 2017.

IDRA
IMO-2125
Cancer - melanoma

Phase 2 Phase 1 portion of trial completed. Phase 2 arm enrolling. Overall response data due 1Q 2018.

ITEK
Trabodenoson and latanoprost
Glaucoma

Phase 2 Phase 2 recruitment completed - noted April 11, 2017. Data due July 2017.

NBIX
INGREZZA
Tardive dyskinesia

Approved Approved April 11, 2017.

NBRV
Lefamulin - LEAP 1
Moderate to severe Community Acquired Bacterial Pneumonia (CABP)

Phase 3 Phase 3 enrollment completion noted April 11, 2017 with data due 3Q 2017.

WINT
Aerosurf
Respiratory Distress Syndrome - premature infants 26 to 32 weeks

Phase 2b Phase 2b interim safety review completed April 11, 2017. Trial to continue to completion. Top-line data due mid 2017.